BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN¿

    MDR report key: 1990941 · Received February 15, 2011

    Report

    Report Number
    2939204-2011-00043
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    August 23, 2010
    Report Date
    January 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. TRANSIENT ISCHEMIC ATTACK IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING OF THE BASILAR AND RIGHT VERTEBRAL ARTERY. HOWEVER, THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) IN THE TERRITORY OF THE TREATED BASILAR ARTERY. THE TIA RESOLVED THE FOLLOWING DAY WITHOUT SEQUELAE. THE PHYSICIAN REPORTED THE TIA WAS UNRELATED TO THE DEVICES.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING OF THE BASILAR AND RIGHT VERTEBRAL ARTERY. HOWEVER, THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) IN THE TERRITORY OF THE TREATED BASILAR ARTERY. THE TIA RESOLVED THE FOLLOWING DAY WITHOUT SEQUELAE. THE PHYSICIAN REPORTED THE TIA WAS POSSIBLY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING OF THE BASILAR AND RIGHT VERTEBRAL ARTERY. HOWEVER, THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) IN THE TERRITORY OF THE TREATED BASILAR ARTERY. THE TIA RESOLVED THE FOLLOWING DAY WITHOUT SEQUELAE. THE PHYSICIAN REPORTED THE TIA WAS UNRELATED TO THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN¿ STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WE0400200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other GATEWAY BALLOON (BOSTON SCIENTIFIC)